August 1, 2012 — Bloomberg reports that Johnson & Johnson’s Synthes unit and a former Noridian Corp. subsidiary company have been sued by the family of a women who died during an unapproved trial of bone cement.
On January 13, 2003, Lois L. Eskind underwent surgery to treat a vertebrae that crumbled due to osteoporosis. She died after a surgeon injected the bone cement mixed with barium sulfate into her spine. The product leaked into her bloodstream and she suffered a sudden, deadly cardiac arrest. Her daughter, Eva Sloan, has since filed a wrongful death lawsuit against Synthes.
In the lawsuit, Sloan claims that Synthes “concealed the illegality, experimental nature and substantial risks of the surgery.” She claims that a bone cement, also known as the Skeletal Repair System (SRS), had already been approved by the U.S. Food and Drug Administration (FDA) to treat vertebral compression fractures.
She accuses the company of conspiring to circumvent the FDA’s time-consuming and expensive clinical testing procedures, which exposed her mother to a deadly medical procedure.
The lawsuit is claiming wrongful death, negligence, fraud, reckless misconduct, conspiracy, loss of consortium, and failure to warn, and was filed in U.S. District Court for the Eastern District of Pennsylvania.
Four senior executives at Synthes have already been convicted of felonies and misdemeanor charges for their role in the unapproved trials. Last year, they were sentenced to prison terms between five and eight months. In the 1990s, the executives noticed that doctors were using bone cement off-label during back operations. Synthes purchased Norian Corp., which already had a bone cement product that the FDA had approved for use in the arm and parts of the skull.
Evidence showed that the executives encouraged surgeons to use the bone cement in back operations, despite the fact that they were receiving reports of serious side effects that occurred during these operations. A vein in the vertebrae carries blood directly to the heart and lungs. Of the 200 people who were injected with the bone cement in their spine, three died of heart attacks — including Eskind. The FDA finally investigated the cases in 2004, and the executives were indicted in 2009. In 2010, Synthes paid a $23.5 million fine.
The families of two other people who died of heart attacks caused by bone cement, Ryoichi Kikuchi and Barbara Marcelino, have also filed lawsuits against Synthes and its executives in California.
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